Submission to review committees
Anyone who wants to carry out scientific research involving the active participation of human subjects is obliged to get the advice of a recognised Medical Research Ethics Committee (MREC). The MREC reviews all research subject to the Medical Scientific Research (Human Subjects) Act (WMO). The goal of the review is, among other things, to safeguard the rights, safety and welfare of the human participants. She weighs scientific interest up against the burden and risks for participants.
WMO or not
Research is subject to the WMO if the following criteria are met:
1. It concerns medical scientific research and
2. Participants are subject to procedures or are required to follow rules of behaviour.
If you're not sure you can find more details and support on the website of the CCMO
To facilitate the review, you are required to compile a standard research file with a number of basic documents. You can find all the necessary information via the links below:
The investigator/submitter is responsible for carrying out a check to verify if all submitted documents comply with various requirements per study type. MREC Amsterdam UMC set up a checklist WMO-submissions and a list of mandatory documents.
In the case of multicenter research, additional documents must be included in the research file. This includes a list of participating centers, Research Declerations or VGOs, the resume of the principal investigator per participating center and a (draft) Clinical Trial Agreement.
There are costs involved with assessing a research file. For more information, see the websites of the MREC Amsterdam UMC.
Please note: effective February 1, 2022, the MREC Amsterdam UMC use new rates for both investigator-initiated studies and commercially sponsored studies.
Submitting your research file to the MREC Amsterdam UMC is done digitally through an online portal : Research Manager
You can find the complete procedure and instructons for submitting a research file on the webpage of the MREC.
For clinical trials involving medicinal products, the European Clinical Trial Regulation (ECTR) is applicable.
The ECTR aims to simplify and accelerate clinical investigations involving medicinal products within the European Union. The regulation ensures that the medical ethical review process is regulated with uniform procedures and established timelines and deadlines, for both the sponsor and the reviewing ethical committee(s).
Sponsors submit the application for the medical ethical review via an EU web portal called Clinical Trial Information System (CTIS). Fore more details see CTIS sponsor handbook and CTIS- online modular training programme .
The ECTR applies to clinical trials involving medicines conducted in Europe. A clinical study falls under the scope of the ECTR if:
1. The clinical, pharmacological or pharmacodynamic effects of a medicinal product are investigated;
2. The study meets one or more of the following conditions:
- Patients or subjects are randomized to a treatment.
- The medicine is prescribed as part of the research and not as part of standard care.
- More or different procedures are performed on the subject than in the context of standard care.
Medicinal research without intervention, such as observational studies into the long-term effects of a medicine, does not meet the standards of the ECTR and is not assessed through CTIS.
See the Clinical Trial Tool (CCMO) to determine if your research falls under the scope of the ECTR.
A low-intervention trial is considered to be a study which is conducted with a registered drug and the subject is minimally burdened and at a minimal risk compared to the standard of care. In this type of research, the ECTR sets less strict requirements for the insurance obligation, Subject Information Letter and the collection of safety information, such as AEs and SAEs.
On this CCMO site you can find a Q&A about the ECTR in the Netherlands.
For further details see the CCMO Site and for local procedures see the CMC Site.
If you have any questions about the submitting procedure within the framework of the CTR, please contact our Clinical Monitoring Center via firstname.lastname@example.org.
Specific rules for the submission, assessment and conduct of clinical investigations with medical devices are set out in the EU Medical Device Regulation (EU no 2017/745, MDR). These rules are described in Chapter 6 of the MDR.
Clinical investigations with medical devices must be assessed in advance by an authorised review committee, as stipulated in the EU Medical Device Regulation (MDR) and/or the Medical Research Involving Human Subjects Act [Wet medisch-wetenschappelijk onderzoek met mensen, WMO].
Investigations should be registered with the CCMO using ToetsingOnline (in 2022 via Eudamed), after which the CCMO will validate the article under which the clinical research falls.
For clinical research in the context of conformity purposes (MDR article 62/74.2) the research file is first validated by CCMO.After a positive decision on the validation, CCMO will transfer your file to the review committee (accredited MREC or CCMO) for assessment. Clinical research with medical devices that are invasive in nature (risk classification II a) and b) or III) fall under article 62 or 74.2 and can only be reviewed by an accredited MREC or the CCMO.
For other clinical investigations (MDR article 82) or post-market clinical follow-up investigations (MDR article 74.1), you may submit a file directly to the MREC.
For further details see the CCMO Site and for local procedures see the website of the MREC Amsterdam UMC.
The CCMO is the authorised agency for registering clinical research using a medical device. This applies to both medical devices without a CE mark as well as medical devices with a CE mark that will be investigated outside the intended usage.
If your research does not fall under the scope of the WMO then it does not have to be reviewed by an accredited MREC or the CCMO. Non-WMO research is submitted to the MREC for advice. If the Executive Board of the MREC has declared your proposed investigation not to be subject to the WMO, you will receive a non-WMO statement.
You can find the whole procedure for submitting a research dossier on the MREC webpage. You will also find a checklist with additional information about which documents you have to submit and how to prepare these.
TcB (Toetsings commissie Biobank) assesses requests to set up biobanks and issues of human tissue from existing biobanks based on the Biobank Assessment Regulations . The Biobank Assessment Committee of the AMC location (BTC) and the Biobank Assessment Committee of the VUmc location (TcB) are now joining forces and will continue as the Biobank Assessment Committee of Amsterdam UMC (in Dutch: Commissie Toetsing Biobanken - CTB). The CTB falls under the responsibility of the MRECs.
For more information and the new Biobank assesment Regulation, visit this page.You will also find a checklist with additional information about which documents you have to submit and how to prepare these.